H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A-H1N1v Vaccination in Pregnant Wome
Phase 1
- Conditions
- Protection against Influenza A H1N1v disease
- Registration Number
- EUCTR2009-016877-14-DK
- Lead Sponsor
- COPSAC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Inclusion criteria
•Healthy pregnant and non-pregnant women living in Eastern Denmark
•Fluent in Danish
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Heart disease, endocrine disease, tuberculosis and sarcoidosis.
•History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method